The study is evaluating Albuferon (albumin-interferon alpha) in combination with ribavirin in patients who are naive to interferon alpha- based treatment regimens. According to Human Genome, Genotype 1 accounts for nearly 70% of all hepatitis C virus (HCV) infections in North America and is generally regarded as the most difficult HCV genotype to treat.
The open-label trial is a dose-ranging study being conducted in many European counties as well as countries outside Europe including Australia and Canada. So far a total of 458 patients with chronic hepatitis C genotype 1 have received initial treatment in the trial.
Patients have been randomized into four treatment groups, three of which receive subcutaneously administered Albuferon in different dose and interval levels. The fourth treatment group serves as the active control group and receives weekly 180-mcg doses of subcutaneously administered Pegasys (peginterferon alfa-2a). All patients receive weight-based oral daily ribavirin at 1000 or 1200 mg in two divided doses.
The primary objectives of the phase IIb study are to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon alpha-naive patients with chronic hepatitis C genotype 1. The primary efficacy endpoint is sustained virologic response, defined as undetectable virus at 24 weeks after completion of 48 weeks of treatment.
“The current standard of care for the treatment of chronic hepatitis C is a combination of pegylated interferon alpha and ribavirin. This combination produces cures in approximately 42-46% of all genotype 1 HCV patients completing therapy, leaving more than 50% who relapse or do not respond. Clearly, chronic hepatitis C represents a significant unmet medical need,” concluded John McHutchison, coordinating center principal investigator for the study, and Professor of Medicine at Duke Clinical Research Institute.